Active clinical trials for "Coronary Artery Disease"

The study of biochemical risk factors for cardiovascular diseases is important not only for analysis, but also for preventive measures, given that changes in the level of biomarkers can be detected before the first clinical manifestations of CVD. Accordingly, patients at high CV risk may have additional motivation to lead a healthy lifestyle. In addition, information on biochemical risk markers can be used to optimize the clinical management of patients.

Coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. However, there is no consensus on analgesic management in patients undergoing CABG. The aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (TTMP) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump CABG surgery. Our main hypothesis is that a bilateral TTMP block performed after CABG surgery could reduce morphine consumption during the first 48 hours. The investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the Montpellier University Hospital (France).

The REDUCE-IT Canada SA Study is a cross-sectional study aiming to determine the proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl (IPE;Vascepa®).

One-center, observational, non-interventional, prospective study of the efficacy of azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus.

This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries. When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down. The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol, combined with a specific breathing maneuver to identify myocardial regions exposed to severe coronary artery stenosis.

It is well established that clopidogrel-induced antiplatelet effects is suboptimal in many patients who are thus exposed to an increased risk of adverse cardiovascular events. Studies have shown that genotypes of the cytochrome P450 (CYP) 2C19 enzyme, which is a key determinant of clopidogrel metabolism, contribute to these findings. Prasugrel and ticagrelor are alternative agents whose effectiveness is not dependent on CYP2C19 genotype. A boxed warning on the Food and Drug Administration (FDA)-approved clopidogrel labeling warns of reduced effectiveness in patients with the LOF genotype and recommends alternative therapies in these patients. The availability of an assay recently approved by the FDA, SpartanRX, which provides results within one-hour facilitates performing genetic testing as a clinical test in real-world practice. We therefore propose to 1) examine the feasibility of implementing CYP2C19 genotyping using SpartanRX as standard of care for patients undergoing cardiac catheterization at UF Health Jacksonville providing the opportunity for clinicians to embrace genotype-guided antiplatelet therapy in those who proceed to PCI and 2) determine if CYP2C19 genotype-guided antiplatelet therapy reduces the risk for major adverse cardiovascular outcomes after PCI.

AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as the long-term clinical results in terms of safety and efficacy of the polymer-free DES technology in all comers patients with an indication to percutaneous coronary intervention. PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC classification (19). PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR). STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective observational registry aiming to enroll a population of 1000 patients. STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last patient in the registry. CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after the index procedure. PATIENTS SELECTION CRITERIA: This is an "all comers" registry and patient who will be enrolled have to meet the sequent criteria: Patient must be at least 18 years of age at the time of signing the Informed Consent Form after Biofreedom placement. All "de novo" lesion subsets are included. Patient must agree to undergo all required follow-up visits and data collection. Patient must have indication to percutaneous coronary intervention following: Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or Unstable angina / non ST-elevation myocardial infarction ST-elevation myocardial infarction with de novo culprit lesion. EXCLUSION CRITERIA: The exclusion criteria must follow the most recent IFU which may include but are not limited to the following: Known intolerance to any of the device components In-stent restenosis Woman with childbearing potential Age < 18y/o Inability to provide written informed consent EFFICACY PARAMETERS: TLR and TVR up to 5-year follow-up. SAFETY "PATIENT ORIENTED" PARAMETERS: all cause mortality, any myocardial infarction, Stent thrombosis based on the ARC classification, up to 5-year follow-up and bleeding occurrence according to BARC classification. Data on dual antiplatelet therapy use will also be collected and analyzed according to duration and cessation modalities. Sample size justification: Being this an observational registry aiming at quantifying effect estimates without direct comparisons to other devices for coronary angioplasty, we relied on confidence interval profiling for sample size justification, without proceeding with formal power analysis. The main analysis will be an overall and comprehensive analysis and it will be planned the primary analytical approach of all-comers patients with coronary artery disease and indication to PCI. Accordingly, we computed that a target sample of 1000 patients will enable the computation of reasonably precise 95% confidence intervals. Specifically, assuming a 8% MACE rate at 1 year (in keeping with RUDY study and LEADERS FREE trial design), confidence intervals computed with the adjusted Wald method would be 7.1% to 9.6% for a 1000-patient sample (point estimate 80/1000 [8.0%]). Given that the registry aims to reflect real-world patients and practice, no prevision to limit or restrict patient enrollment is considered. Analytical plan: Continuous endpoints will be summarized by presenting the total number of patients, mean, standard deviation, median, minimum, and maximum. Tabulation of categorical parameters will include counts and percentages. The outcomes will be summarized as both a discrete and a continuous variable using the method described above. Survival analysis will be performed with the Kaplan-Meier method. Statistical inference will be based on the computation of 95% confidence intervals using the adjusted Wald method. Additional analyses will involve key subgroups defined according to baseline, lesion, and procedural features, with statistical significance set at the 5% 2-tailed level. Specifically, Student t, Fisher exact, and log-rank tests will be used for such bivariate analyses, whereas multivariable linear regression, logistic regression, and Cox proportional hazard analyses will be used to adjust for confounders.

Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.

This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.